The most important proposed change from last year's QIP rule (PDF link) is the elimination of the Clinical Performance Measure (CPM): "percentage of patients at a facility whose hemoglobin (Hgb) levels were less than 10 grams per deciliter (Hgb=10)". I supported the below 10 penalty in my 2010 comments because I felt that the inherent nature of the bundle would put a tremendous downward pressure on the use of the class of ESRD anemia correcting medications called, Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp.

This proposed elimination comes in light of the FDA's new lable which recommends:

For patients with CKD, consider starting ESA treatment when the hemoglobin level is less than 10 g/dL. This advice does not define how far below 10 g/dL is appropriate for an individual to initiate. This advice also does not recommend that the goal is to achieve a hemoglobin of 10 g/dL or a hemoglobin above 10 g/dL. Individualize dosing and use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions. Adjust dosing as appropriate.

The drug label previously recommended that ESAs should be dosed to achieve and maintain hemoglobin levels within the target range of 10 to 12 g/dL in CKD patients. This target concept has been removed from the label.

In order to put the QIP in concert with the label change (as required by Section 153(c) of MIPPA) CMS proposes to use just two measures for the 2013 QIP penalties (based on 2011 outcomes) Hgb >12 and URR <65%. The proposed rule also includes a payment update of 1.8% (the first in the program's history that did not require a specific Act of Congress) and eight future measures (2012 performance; 2014 payment):

Dialysis adequacy, as measured through the Kt/V method, which is widely recognized as a more accurate measure of whether dialysis cleanses blood effectively

Anemia management, as measured by the rate of patients with a hemoglobin level greater than 12 grams per deciliter;

Percent of patients receiving treatment through an arteriovenous fistula – a type of vascular access used to connect patients’ bloodstreams to dialysis equipment for cleansing;

Rates of infection of the vascular access sites;

Ratios of hospitalization rates among dialysis clinic patients;

Whether the facility reports certain dialysis-related infections to the Centers for Disease Control & Prevention;

Whether the facility administers a patient experience of care survey; and

Whether the facility monitors phosphorus and calcium levels on a monthly basis.

In my comment I will propose that CMS stop including any Hgb numbers in its QIP and instead stake half of the QIP penalty (1% of unit reimbursement) on "percentage of patients at a facility whose hemoglobin grams per deciliter levels were more or less than ten percent of the Monthly Capitated Payment (MCP) Physician's target Hgb for that beneficiary".

In their final rule, CMS should propose using 2012 outcomes as a benchmark and implement this new CPM in 2013 effecting payment in 2015.

I believe this makes sense because CMS is paying the MCP Physician to manage their beneficiary's renal replacement therapy, including anemia management. Thus it is appropriate that the QIP motivate units to put the MCP Physician's clinical judgement into practice.

I like this approach because the dialyzor can be included in the discussion to set the target and the doctor can take the dialyzor's view on the trade off between a Hgb of 11 v a Hgb of 9 into consideration when setting an individualized goal.

One concern will be how to collect the information, how to report the MCP Physician's Hgb target. I suggest including the target with the reporting requirement noting for ESA Route of Administration. Starting in 2012 units are required to include the modifiers JA (intravenous administration) or JB (subcutaneous administration) indicating the route of administration on all ESRD claims with dates of service on or after January 1, 2012 (PDF link). Along with the route of administration, units should also be required to report beneficiary's MCP Physician's Hgb target. From there it is a simple math equation to determine if the unit's performance was within 10% of the target.

The other concern is what will happen between now and when a more appropriate CPM can be implemented in 2013? With their final rule Medicare must send the message that they expect units to provide the care prescribed by the MCP Physician and act with deliberate haste to align the QIP with outcomes that matter to the dialyzed and enable CMS to meet the intent of the MIPPA (Section 153c) legislation: to motivate the safe achievement of optimal outcomes.